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NCT01131559 Clinical Trial

Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Depression Clinical Trial

Official title:
Adjunctive Lisdexamfetamine in Bipolar Depression

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01131559
Other study ID # Adjunctive LDX in BP
Secondary ID
Status Terminated
Phase Phase 3
First received March 19, 2010
Last updated March 4, 2014
Start date January 2010
Est. completion date February 2014

Study information
Verified date March 2014
Source Lindner Center of HOPE
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,

Exclusion Criteria:

- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.

- Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lisdexamfetamine
Oral; 20-70mg/day
• Placebo control
Oral; 20-70mg/day

Locations
Country Name City State
United States Lindner Center of HOPE Mason Ohio

Sponsors (3)
Lead Sponsor Collaborator
Lindner Center of HOPE Shire, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in MADRS score The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score. 30-36 months Yes
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